Cromolyn Sodium Inhalation Solution 20 mg/2mL
Cromolyn Sodium Inhalation Solution · SOLUTION · Ritedose Pharmaceuticals, LLC
Cromolyn Sodium Inhalation Solution is a solution containing cromolyn sodium inhalation solution at 20 mg/2mL, taken respiratory (inhalation). Manufactured by Ritedose Pharmaceuticals, LLC.
Key Facts
- Brand Name
- Cromolyn Sodium Inhalation Solution
- Generic Name
- Cromolyn Sodium Inhalation Solution
- NDC Code (Product)
76204-028- Manufacturer
- Ritedose Pharmaceuticals, LLC
- Strength
- 20 mg/2mL
- Dosage Form
- SOLUTION
- Route
- RESPIRATORY (INHALATION)
- Marketing Status
- Application #
- ANDA209453
- Marketing Start
- 12/01/2021
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
Indications and Usage Cromolyn sodium inhalation solution USP is a prophylactic agent indicated in the management of patients with bronchial asthma. In patients whose symptoms are sufficiently frequent to require a continuous program of medication, cromolyn sodium inhalation solution USP is given by inhalation on a regular daily basis (see DOSAGE AND ADMINISTRATION ). The effect of cromolyn sodium is usually evident after several weeks of treatment, although some patients show an almost immediate response. In patients who develop acute bronchoconstriction in response to exposure to exercise, toluene diisocyanate, environmental pollutants, etc., cromolyn sodium should be given shortly before exposure to the precipitating factor (see DOSAGE AND ADMINISTRATION ).
Dosage & Administration
Dosage and Administration For management of bronchial asthma in adults and pediatric patients (two years of age and over), the usual starting dosage is the contents of one vial administered by nebulization four times a day at regular intervals. Drug stability and safety of cromolyn sodium inhalation solution when mixed with other drugs in a nebulizer have not been established. Patients with chronic asthma should be advised that the effect of cromolyn sodium inhalation solution therapy is dependent upon its administration at regular intervals, as directed. Cromolyn sodium inhalation solution should be introduced into the patient's therapeutic regimen when the acute episode has been controlled, the airway has been cleared and the patient is able to inhale adequately. For the prevention of acute bronchospasm which follows exercise or exposure to cold dry air, environmental agents (e.g., animal danders, toluene diisocyanate, pollutants), etc., the usual dose is the contents of one vial administered by nebulization shortly before exposure to the precipitating factor. It should be emphasized to the patient that the drug is poorly absorbed when swallowed and is not effective by this route…
Warnings
Warnings Cromolyn sodium inhalation solution has no role in the treatment of status asthmaticus. Anaphylactic reactions with cromolyn sodium administration have been reported rarely.
Contraindications
Contraindications Cromolyn sodium inhalation solution is contraindicated in those patients who have shown hypersensitivity to cromolyn sodium.
Adverse Reactions
Adverse Reactions Clinical experience with the use of cromolyn sodium suggests that adverse reactions are rare events. The following adverse reactions have been associated with cromolyn sodium: cough, nasal congestion, nausea, sneezing, and wheezing. Other reactions have been reported in clinical trials; however, a causal relationship could not be established: drowsiness, nasal itching, nose bleed, nose burning, serum sickness, and stomachache. In addition, adverse reactions have been reported with cromolyn sodium for inhalation capsules. The most common side effects are associated with inhalation of the powder and include transient cough (1 in 5 patients) and mild wheezing (1 in 25 patients). These effects rarely require treatment or discontinuation of the drug. Information on the incidence of adverse reactions to cromolyn sodium for inhalation capsules has been derived from U.S. postmarketing surveillance experience. The following adverse reactions attributed to cromolyn sodium, based upon recurrence following readministration, have been reported in less than 1 in 10,000 patients: laryngeal edema, swollen parotid gland, angioedema, bronchospasm, joint swelling and pain, dizziness…
Frequently Asked Questions
What is Cromolyn Sodium Inhalation Solution used for?
Cromolyn Sodium Inhalation Solution contains Cromolyn Sodium Inhalation Solution. It is a solution taken respiratory (inhalation). Consult your doctor for specific uses.
Is Cromolyn Sodium Inhalation Solution a controlled substance?
Cromolyn Sodium Inhalation Solution is not classified as a controlled substance by the DEA.
What is the generic name for Cromolyn Sodium Inhalation Solution?
The generic name for Cromolyn Sodium Inhalation Solution is Cromolyn Sodium Inhalation Solution. There are no other listed brand versions of Cromolyn Sodium Inhalation Solution.
What is the NDC code for Cromolyn Sodium Inhalation Solution 20 mg/2mL?
The NDC (National Drug Code) for Cromolyn Sodium Inhalation Solution 20 mg/2mL is 76204-028, listed by Ritedose Pharmaceuticals, LLC.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)